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Aerobic Exercise for Alzheimer's Disease (BIMII Trial)

Q: Are there any vacancies left for participants in this clinical research?

<p>According to the clinicaltrials.gov website, this research initiative is currently welcoming individuals who meet certain criteria. The project was inaugurated on January 1st 2017 and its details were most recently edited on November 2nd 2022.</p>

Q: How many test subjects have been recruited to be part of this clinical trial?

<p>Affirmative. Clinicaltrials.gov verifies that this clinical trial is currently welcoming participants, with the original post dating back to January 1st 2017 and most recent update from November 2nd 2022. The study requires 264 patients from a single location for enrollment.</p>

N/A

Recruiting

Led By Marc J Poulin, PhD, DPhil

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed at 6, 12 and 18 months.

Awards & highlights

BIMII Trial Summary

This trial will test an exercise intervention for secondary prevention of ADRD in adults at increased risk for ADRD. The rationale for this trial is the urgent need for dementia prevention.

Who is the study for?

This trial is for inactive adults aged 50-80 with memory complaints but no dementia, and at least one vascular risk factor like high blood pressure or diabetes. They should not be doing vigorous exercise more than twice a week and must speak English fluently. People with serious illnesses, history of stroke, or other conditions that could affect the study can't join.Check my eligibility

What is being tested?

The trial tests if regular aerobic exercise can prevent or slow down cognitive decline in older adults at risk of Alzheimer's Disease and related dementias (ADRD). Participants will do either aerobic exercises or stretching-toning exercises to see which helps brain health and cognition more.See study design

What are the potential side effects?

While the trial focuses on beneficial effects, potential side effects from increased physical activity may include muscle soreness, fatigue, joint pain, and an elevated risk of injury. The intensity will be monitored to minimize these risks.

BIMII Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed at 6, 12 and 18 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed at 6, 12 and 18 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed at 6, 12 and 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cognition Assessed by Neuropsychological Test Battery

Secondary outcome measures

Change in Blood Biomarkers Assessed by Elisa Assays

Change in Brain Structure and Function Assessed by Neuroimaging Modalities

Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound

+4 more

BIMII Trial Design

2Treatment groups

Experimental Treatment

Group I: Stretch and StrengthExperimental Treatment1 Intervention

A control group will meet on a similar schedule as the exercise group for sessions on stretching and toning but without aerobic exercise. Based on prior RCTs of similar interventions the investigators expect this control to be ineffective or minimally effective, but anticipate that it will increase participant enthusiasm and retention. All assessments will be conducted in this arm.

Group II: Aerobic exerciseExperimental Treatment1 Intervention

Participants will take part in a supervised 6-month-long aerobic (walk/jog) training program held 3 days/week. Each session will include a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions will follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cool-down, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise will increase from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity will be based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity will build from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic exercise

2000

Completed Phase 2

~1130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,341 Previous Clinical Trials

26,452,449 Total Patients Enrolled

16 Trials studying Dementia

1,278,828 Patients Enrolled for Dementia

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,470 Total Patients Enrolled

5 Trials studying Dementia

1,040 Patients Enrolled for Dementia

Marc J Poulin, PhD, DPhilPrincipal InvestigatorUniversity of Calgary

3 Previous Clinical Trials

322 Total Patients Enrolled

Media Library

Aerobic exercise Clinical Trial Eligibility Overview. Trial Name: NCT03035851 — N/A

Dementia Research Study Groups: Aerobic exercise, Stretch and Strength

Dementia Clinical Trial 2023: Aerobic exercise Highlights & Side Effects. Trial Name: NCT03035851 — N/A

Aerobic exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03035851 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include elderly patients as participants?

"This research project is open to patients who are within the ages of 50 and 80."

Answered by AI

Who meets the qualifications to take part in this research endeavor?

"This study is actively seeking 264 men and women between the ages of 50-80 who are experiencing cognitive decline, but have yet to be diagnosed with dementia. These candidates must also meet certain risk factors such as inactivity (as gauged by a physical activity questionnaire), obesity, hypertension, smoking history, and prior coronary artery disease without recent symptoms (<5 years). Additionally all potential participants must provide approval from their doctor or receive information on how to locate one for that purpose using a PAR-Q+ form. Lastly subjective cognitive complaints will be measured via MAC-Q Memory Complaint Questionnaire; those scoring above 25 will qualify for enrolment."

Answered by AI

Are there any vacancies left for participants in this clinical research?

"According to the clinicaltrials.gov website, this research initiative is currently welcoming individuals who meet certain criteria. The project was inaugurated on January 1st 2017 and its details were most recently edited on November 2nd 2022."

Answered by AI

How many test subjects have been recruited to be part of this clinical trial?

"Affirmative. Clinicaltrials.gov verifies that this clinical trial is currently welcoming participants, with the original post dating back to January 1st 2017 and most recent update from November 2nd 2022. The study requires 264 patients from a single location for enrollment."

Answered by AI

Recent research and studies

TrialsJournal

The Brain in Motion II Study: Study Protocol for a Randomized Controlled Trial of an Aerobic Exercise Intervention for Older Adults at Increased Risk of Dementia

Krüger, Renata L., Cameron M. Clark, Adrienna M. Dyck, Todd J. Anderson, Fiona Clement, Patrick J. Hanly, Heather M. Hanson, et al.. 2021. “The Brain in Motion II Study: Study Protocol for a Randomized Controlled Trial of an Aerobic Exercise Intervention for Older Adults at Increased Risk of Dementia”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05336-z.

clinicaltrials.govStudy

Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias

Marc Poulin 2017. "Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03035851.

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